Data Consistent with Immunogenicity and Safety Data from Previous Studies
NEW YORK, NY, USA I August 21, 2015 I Pfizer Inc. (NYSE:PFE) announced today positive topline results of two Phase 3 studies of TRUMENBA® (Meningococcal Group B Vaccine). One study included approximately 3,600 healthy individuals 10 through 18 years of age, and the other study included approximately 3,300 healthy individuals 18 through 25 years of age. Both studies met all primary immunogenicity endpoints, demonstrating robust immune responses against certain invasive meningococcal B strains after the vaccine dose series. Safety and tolerability data from both studies were also consistent with data from previous studies.
“We are very pleased with these Phase 3 data that show immunogenicity and safety data consistent with findings that formed the basis for the accelerated FDA approval of TRUMENBA,” said Kathrin Jansen, Ph.D., senior vice president of Vaccine Research and Development for Pfizer Inc. “The Phase 3 data extend the body of evidence that supports vaccination of adolescents and young adults with TRUMENBA to help prevent serogroup B meningococcal disease.”
In October 2014, Pfizer’s TRUMENBA® (Meningococcal Group B Vaccine) was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
Pfizer plans to present the full results of both studies at an upcoming scientific congress.
Phase 3 Study Designs
Vaccine safety and immunogenicity were evaluated in these two Phase 3 studies.
One Phase 3 study was a randomized, active-controlled, observer-blinded study that included approximately 3,600 healthy individuals 10 through 18 years of age in the United States and Europe. Individuals were randomized to receive one of three different lots of TRUMENBA® in a 0, 2, 6 month schedule or a control. The control group received a licensed hepatitis A (HAV) vaccine at 0 and 6 months and saline at 2 months. The primary endpoints assessed immunogenicity, lot consistency and safety.
Immunogenicity: Demonstration of an immune response measured by serum bactericidal assays with human complement (hSBA) for 4 primary test strains 1 month after the third vaccination with TRUMENBA
Lot consistency: hSBA geometric mean titers (GMTs) for 2 primary test strains (A22 and B24) measured 1 month after the third vaccination for individuals receiving one of three different lots of TRUMENBA
Safety: Proportion of subjects who reported local and systemic reactions, adverse events (AE), serious adverse events (SAE), newly diagnosed chronic medical conditions (NDCMC), medically-attended adverse events (MAE), autoimmune diseases and neuroinflammatory conditions following vaccination with TRUMENBA or a control
A second Phase 3 study was a randomized, placebo-controlled, observer-blinded study that included approximately 3,300 healthy individuals 18 through 25 years of age in the United States and Europe. Individuals were randomized to receive TRUMENBA® or a saline control in a 0, 2, 6 month schedule. The primary endpoints assessed immunogenicity and safety.
Immunogenicity: Demonstration of an immune response measured by hSBA for 4 primary test strains 1 month after the third vaccination with TRUMENBA
Safety: Proportion of subjects who reported local and systemic reactions, AEs, SAEs, NDCMCs, MAEs, autoimmune diseases and neuroinflammatory conditions following vaccination with TRUMENBA or placebo
U.S. Indication for TRUMENBA® (Meningococcal Group B Vaccine)
TRUMENBA® (Meningococcal Group B Vaccine) is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
Approval of TRUMENBA is based on the demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the United States. The effectiveness of TRUMENBA against diverse serogroup B strains has not been confirmed.
Important Safety Information
TRUMENBA® should not be given to anyone with a history of a severe allergic reaction after a previous dose of TRUMENBA.
Individuals with weakened immune systems may have a reduced immune response.
The most common adverse reactions were pain at the injection site, fatigue, headache, muscle pain, and chills.
Data are not available on the safety and effectiveness of using TRUMENBA and other meningococcal group B vaccines interchangeably to complete the vaccination series.
Tell your healthcare provider if you are pregnant, or plan to become pregnant.
Ask your healthcare provider about the risks and benefits of TRUMENBA. Only a healthcare provider can decide if TRUMENBA is right for you or your child.
You are encouraged to report negative side effects of vaccines to the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or call 1-800-822-7967.
For the full prescribing information for TRUMENBA, please visit www.trumenba.com.
About TRUMENBA® (Meningococcal Group B Vaccine)
TRUMENBA® is a sterile suspension composed of two recombinant lipidated factor H binding protein (fHBP) variants from N. meningitidis serogroup B, one from fHBP subfamily A and one from subfamily B (A05 and B01, respectively). fHBP is one of many proteins found on the surface of meningococci and contributes to the ability of the bacterium to avoid host defenses. fHBPs can be categorized into two immunologically distinct subfamilies, A and B. The susceptibility of serogroup B meningococci to complement-mediated, antibody-dependent killing following vaccination with TRUMENBA is dependent on both the antigenic similarity of the bacterial and vaccine fHBPs, as well as the amount of fHBP expressed on the surface of the invading meningococci.1
As with any vaccine, TRUMENBA may not prevent disease in all vaccinated individuals. The frequency of meningococcal disease caused by serogroup B varies geographically, and could influence the ability to evaluate effectiveness of the vaccine in any given country. Based on the low incidence of meningococcal disease, placebo-controlled clinical trials for TRUMENBA were considered unfeasible due to the size of the study that would be required and were not performed. Licensure of TRUMENBA was based on demonstration of immune responses measured using a serum bactericidal assay with human complement (hSBA).
In 2014, TRUMENBA was reviewed and received accelerated approval under the FDA’s Breakthrough Therapy designation and Priority Review programs.
About Serogroup B Meningococcal Disease
The majority of invasive meningococcal disease cases worldwide can be attributed to five Neisseria meningitidis serogroups (A, B, C, W and Y).2 Meningococcal serogroup B disease affects all age groups in the U.S., but incidence is highest among infants younger than one year, adolescents and young adults.3 In 2013, approximately 500 cases of meningococcal disease occurred in the United States, more than 30 percent of which were caused by serogroup B.4
Serogroup B meningococcal disease may result in life-altering, significant long-term and permanent medical disabilities.5,6,7 Despite the availability of antibiotic treatment, 12.5 percent of patients with meningococcal serogroup B disease die and many of those who survive are afflicted with long-term disabilities, such as brain damage, hearing loss, learning disabilities or limb amputations.8,9
Pfizer Inc.: Working together for a healthier world™
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at www.pfizer.com.
SOURCE: Pfizer
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Data Consistent with Immunogenicity and Safety Data from Previous Studies
NEW YORK, NY, USA I August 21, 2015 I Pfizer Inc. (NYSE:PFE) announced today positive topline results of two Phase 3 studies of TRUMENBA® (Meningococcal Group B Vaccine). One study included approximately 3,600 healthy individuals 10 through 18 years of age, and the other study included approximately 3,300 healthy individuals 18 through 25 years of age. Both studies met all primary immunogenicity endpoints, demonstrating robust immune responses against certain invasive meningococcal B strains after the vaccine dose series. Safety and tolerability data from both studies were also consistent with data from previous studies.
“We are very pleased with these Phase 3 data that show immunogenicity and safety data consistent with findings that formed the basis for the accelerated FDA approval of TRUMENBA,” said Kathrin Jansen, Ph.D., senior vice president of Vaccine Research and Development for Pfizer Inc. “The Phase 3 data extend the body of evidence that supports vaccination of adolescents and young adults with TRUMENBA to help prevent serogroup B meningococcal disease.”
In October 2014, Pfizer’s TRUMENBA® (Meningococcal Group B Vaccine) was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
Pfizer plans to present the full results of both studies at an upcoming scientific congress.
Phase 3 Study Designs
Vaccine safety and immunogenicity were evaluated in these two Phase 3 studies.
One Phase 3 study was a randomized, active-controlled, observer-blinded study that included approximately 3,600 healthy individuals 10 through 18 years of age in the United States and Europe. Individuals were randomized to receive one of three different lots of TRUMENBA® in a 0, 2, 6 month schedule or a control. The control group received a licensed hepatitis A (HAV) vaccine at 0 and 6 months and saline at 2 months. The primary endpoints assessed immunogenicity, lot consistency and safety.
Immunogenicity: Demonstration of an immune response measured by serum bactericidal assays with human complement (hSBA) for 4 primary test strains 1 month after the third vaccination with TRUMENBA
Lot consistency: hSBA geometric mean titers (GMTs) for 2 primary test strains (A22 and B24) measured 1 month after the third vaccination for individuals receiving one of three different lots of TRUMENBA
Safety: Proportion of subjects who reported local and systemic reactions, adverse events (AE), serious adverse events (SAE), newly diagnosed chronic medical conditions (NDCMC), medically-attended adverse events (MAE), autoimmune diseases and neuroinflammatory conditions following vaccination with TRUMENBA or a control
A second Phase 3 study was a randomized, placebo-controlled, observer-blinded study that included approximately 3,300 healthy individuals 18 through 25 years of age in the United States and Europe. Individuals were randomized to receive TRUMENBA® or a saline control in a 0, 2, 6 month schedule. The primary endpoints assessed immunogenicity and safety.
Immunogenicity: Demonstration of an immune response measured by hSBA for 4 primary test strains 1 month after the third vaccination with TRUMENBA
Safety: Proportion of subjects who reported local and systemic reactions, AEs, SAEs, NDCMCs, MAEs, autoimmune diseases and neuroinflammatory conditions following vaccination with TRUMENBA or placebo
U.S. Indication for TRUMENBA® (Meningococcal Group B Vaccine)
TRUMENBA® (Meningococcal Group B Vaccine) is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
Approval of TRUMENBA is based on the demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the United States. The effectiveness of TRUMENBA against diverse serogroup B strains has not been confirmed.
Important Safety Information
TRUMENBA® should not be given to anyone with a history of a severe allergic reaction after a previous dose of TRUMENBA.
Individuals with weakened immune systems may have a reduced immune response.
The most common adverse reactions were pain at the injection site, fatigue, headache, muscle pain, and chills.
Data are not available on the safety and effectiveness of using TRUMENBA and other meningococcal group B vaccines interchangeably to complete the vaccination series.
Tell your healthcare provider if you are pregnant, or plan to become pregnant.
Ask your healthcare provider about the risks and benefits of TRUMENBA. Only a healthcare provider can decide if TRUMENBA is right for you or your child.
You are encouraged to report negative side effects of vaccines to the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or call 1-800-822-7967.
For the full prescribing information for TRUMENBA, please visit www.trumenba.com.
About TRUMENBA® (Meningococcal Group B Vaccine)
TRUMENBA® is a sterile suspension composed of two recombinant lipidated factor H binding protein (fHBP) variants from N. meningitidis serogroup B, one from fHBP subfamily A and one from subfamily B (A05 and B01, respectively). fHBP is one of many proteins found on the surface of meningococci and contributes to the ability of the bacterium to avoid host defenses. fHBPs can be categorized into two immunologically distinct subfamilies, A and B. The susceptibility of serogroup B meningococci to complement-mediated, antibody-dependent killing following vaccination with TRUMENBA is dependent on both the antigenic similarity of the bacterial and vaccine fHBPs, as well as the amount of fHBP expressed on the surface of the invading meningococci.1
As with any vaccine, TRUMENBA may not prevent disease in all vaccinated individuals. The frequency of meningococcal disease caused by serogroup B varies geographically, and could influence the ability to evaluate effectiveness of the vaccine in any given country. Based on the low incidence of meningococcal disease, placebo-controlled clinical trials for TRUMENBA were considered unfeasible due to the size of the study that would be required and were not performed. Licensure of TRUMENBA was based on demonstration of immune responses measured using a serum bactericidal assay with human complement (hSBA).
In 2014, TRUMENBA was reviewed and received accelerated approval under the FDA’s Breakthrough Therapy designation and Priority Review programs.
About Serogroup B Meningococcal Disease
The majority of invasive meningococcal disease cases worldwide can be attributed to five Neisseria meningitidis serogroups (A, B, C, W and Y).2 Meningococcal serogroup B disease affects all age groups in the U.S., but incidence is highest among infants younger than one year, adolescents and young adults.3 In 2013, approximately 500 cases of meningococcal disease occurred in the United States, more than 30 percent of which were caused by serogroup B.4
Serogroup B meningococcal disease may result in life-altering, significant long-term and permanent medical disabilities.5,6,7 Despite the availability of antibiotic treatment, 12.5 percent of patients with meningococcal serogroup B disease die and many of those who survive are afflicted with long-term disabilities, such as brain damage, hearing loss, learning disabilities or limb amputations.8,9
Pfizer Inc.: Working together for a healthier world™
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at www.pfizer.com.
SOURCE: Pfizer
Post Views: 130
